MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number	80201
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos and images were provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a recanalization procedure in the superficial femoral artery via the groin access as the blood flow was partially restored after the first suction, the surgeon decided to continue the suction and during the suction, the coiled spring inside the catheter suddenly broke with the guide wire being intact.It was further reported that, great resistance was encountered during the withdrawal of the coiled spring.Furthermore, the surgeon repeatedly adjusted the angle and strength, and the coiled spring at the proximal end of the catheter and the entire outer catheter was successfully withdrawn, while the distal spring and the rotary cutting head end remained in the body.Reportedly, after the surgeon treatment, the distal spring and rotary cutting head end together with the outer sheath withdrawn from the body.There was no reported patient injury.
Event or Problem Description
It was reported that during a recanalization procedure in the superficial femoral artery via the groin access as the blood flow was partially restored after the first suction, the surgeon decided to continue the suction and during the suction, the coiled spring inside the catheter suddenly broke with the guide wire being intact.It was further reported that, great resistance was encountered during the withdrawal of the coiled spring.Furthermore, the surgeon repeatedly adjusted the angle and strength, and the coiled spring at the proximal end of the catheter and the entire outer catheter was successfully withdrawn, while the distal spring and the rotary cutting head end remained in the body.Reportedly, after the surgeon treatment, the distal spring and rotary cutting head end together with the outer sheath was withdrawn from the body.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation and a physical investigation was not possible.The user provided report contains information regarding helix break.Provided image shows broken helix.Therefore, the investigation is confirmed for the reported helix break issue.The user reported mechanical jam was not confirmed due to no sample was received.The set lot number was not provided in the report and it was not possible to identify it.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ROTAREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18037345
• Report Number: 3008439199-2023-00187
• Device Sequence Number: 7344770
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 80201
• Device Lot Number: 230660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown